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Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer

ConditionsAntibody-drug ConjugatesHER2-low Breast CancerBreast Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSun Yat-sen University

About this trial

This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.

This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)

Received sequential administration of two or more ADCs

Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.

Disqualifiers

Concomitant with other tumor components at the time of diagnosis;

Have a history of any other malignant tumors;

Lack of complete data

Trial population

Patients diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative) who received sequential administration of two or more antibody-drug conjugates (ADCs).

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Non-intervention research

    Other intervention

    Non-intervention research

Treatment groups

700 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan1 intervention
Group B: First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan1 intervention
Group C: First-line RC48 → Second-line Trastuzumab Deruxtecan1 intervention
Group D: First-line Trastuzumab Deruxtecan → Second-line RC481 intervention
Group E: First-line SKB264 → Second-line Trastuzumab Deruxtecan1 intervention
Group F: First-line Trastuzumab Emtansine → Second-line TQB21021 intervention
Group G: First-line TQB2102 → Second-line Trastuzumab Deruxtecan1 intervention
Group H: First-line RC48 → Second-line TQB21021 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Time frame
From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

Secondary outcomes

1

Overall survival

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.

Time frame
From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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